510(k) Clearances in 2023 — Page 58

3,346 510(k) clearances total

Browse FDA 510(k) clearances granted in 2023. RegDataLab tracks 3,346 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2023 (page 58 of 67)
510(k) clearancesDetails
K221713 — Polypectomy SnareHangzhou AGS MedTech Co., Ltd. Mar 3, 2023
K222573 — imani i2Plus Breast PumpImani Co. Mar 3, 2023
K221661 — Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc. Mar 3, 2023
K230256 — Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG Mar 3, 2023
K223589 — Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. Mar 3, 2023
K230009 — EZ Bond UniversalMeta Biomed Co., Ltd. Mar 3, 2023
K222447 — FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemAbbott Diabetes Care, Inc. Mar 3, 2023
K212696 — Aspira Pleural Drainage SystemMerit Medical Systems, Inc. Mar 3, 2023
K221084 — Dyna Locking Trochanteric Nail™Innosys Mar 3, 2023
K221697 — INJECTION PIN (KIP(02031-02061) (03031-03061))Slk Ortho, LLC Mar 3, 2023
K222880 — Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)Endolumik, Inc. Mar 3, 2023
K230236 — Lyra Influenza A+B AssayQuidel Corporation Mar 3, 2023
K221652 — NIKKICARTRenal Care Dialysis Solutions, S.A. DE C.V. Mar 3, 2023
K223352 — TenderfootAccriva Diagnostics, Inc. Mar 2, 2023
K223440 — Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts Mar 2, 2023
K223436 — Artix AXInari Medical Mar 2, 2023
K223203 — 1.5T 24E Posterior ArrayShenzhen RF Tech Co., Ltd. Mar 2, 2023
K223453 — Insulin SyringePromisemed Hangzhou Meditech Co., Ltd. Mar 2, 2023
K222884 — Rapid NCCT StrokeIschemaview, Inc. Mar 2, 2023
K221696 — ReWalk P6.0Re Walk Robotics , Ltd. Mar 2, 2023
K222603 — 6F Wallaby Long SheathWallaby Medical, Inc. Mar 2, 2023
K223628 — NEBA® Compact EEG2R Mobile HeadsetNeba Health, LLC Mar 2, 2023
K223602 — Traumatic brain injury (TBI) testAbbott Laboratories Mar 2, 2023
K230093 — Disposable 4 Layers Surgical Face MaskSocial Medical Supply, LLC Mar 2, 2023
K221340 — iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)Boston Scientific Corporation Mar 2, 2023
K223902 — FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)Echosens Mar 2, 2023
K230253 — OPTRELL™ Mapping Catheter with TRUEref™ TechnologyBiosense Webster, Inc. Mar 2, 2023
K230303 — AccuFFRangio PlusArteryFlow Technology Co., Ltd. Mar 2, 2023
K222176 — BoneViewGleamer Mar 2, 2023
K230308 — Alma HarmonyAlma Lasers, Inc. Mar 1, 2023
K223144 — Galaxy SystemNoah Medical Corp. Mar 1, 2023
K221053 — Magnes-C Anterior Cervical Plate SystemFellowship Of Orthopaedic Researchers, Inc. Mar 1, 2023
K223040 — Endo SmartCapMedivators, Inc. Mar 1, 2023
K222975 — Advantis PlatformAdvantis Medical Imaging Single Member P.C. Mar 1, 2023
K223423 — 32HQ713DLg Electronics.Inc Mar 1, 2023
K222280 — Bigfoot Unity® Diabetes Management SystemBigfoot Biomedical, Inc. Mar 1, 2023
K222187 — Multistage Balloon Dilatation CatheterDongguan TT Medical, Inc. Mar 1, 2023
K230283 — Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)ABBOTT MEDICAL Mar 1, 2023
K221680 — Xeleris V Processing and Review SystemGE Healthcare Mar 1, 2023
K220014 — RSHOCKSwims America Corp Mar 1, 2023
K213898 — ProTrack Pigtail WireBaylis Medical Company, Inc. Mar 1, 2023
K221790 — HARMONIC 700 ShearsEthicon Endo-Surgery, LLC Feb 28, 2023
K223272 — SurBlate Ablation SystemMima-Pro Scientific, Inc. Feb 28, 2023
K221257 — SpectraWAVE Imaging SystemSpectrawave, Inc. Feb 28, 2023
K223618 — IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RDShenzhen Ulike Smart Electronics Co., Ltd. Feb 28, 2023
K221641 — Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)Terragene S.A. Feb 28, 2023
K221705 — U2 Total Knee System-PF+United Orthopedic Corporation Feb 28, 2023
K222481 — PuraStat3-D Matrix, Inc. Feb 28, 2023
K222240 — EXPLORER AIR® IISurgvision GmbH Feb 28, 2023
K223392 — REVCON (TM) Screw SystemVoom Medical Devices, Inc. Feb 28, 2023
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